English - SORIN GROUP Perceval S Dual Collapser Serie Instrucciones De Uso

ENGLISH

DUAL COLLAPSER FOR PERCEVAL S SUTURELESS AORTIC
This booklet contains important information on use of the Dual Collapser for the
Perceval S sutureless aortic valve. All personnel responsible for handling and
implantation of the Perceval S valve are strongly advised to read and assimilate the
information in this booklet before using the Perceval S sutureless aortic valve Dual
Collapser. The instructions supplied with each prosthesis should also be consulted for
details regarding the Perceval S sutureless aortic valve and procedures for its
mounting on the holder. Perceval S implantation shall be performed only by physician
and associated staff trained on Perceval S preparation and implantation technique.
DESCRIPTION
The Perceval S Dual Collapser (Fig. 1) comprises two ring-like arrays of rigid
elements (1) linked to a main body (2) so that by activating a lever (3) these elements
feature an obturator-like movement allowing Perceval S prosthesis inflow and outflow
ring diameter reduction. The main body presents a connecting element (4), intended
to be fixed to the Dual Collapser Base, and three positioning teeth (5) that hold the
valve in place for correct, guided collapsing and assembly to the holder.
AVAILABLE MODELS
The Dual Collapser is available in different sizes as detailed in the following table;
each size is dedicated to two valve sizes and is reported on the lever.
REF
ICV1235 PERCEVAL S DUAL COLLAPSER S/M
ICV1236 PERCEVAL S DUAL COLLAPSER L/XL
INDICATIONS
The Perceval S Dual Collapser is designed to reduce the prosthesis diameter thus
allowing its mounting on the Dual holder prior to implant.
CONTRA-INDICATIONS
There are no specific contra-indications associated with use of the Perceval S Dual
Collapser.
PACKAGING
The Dual Collapser is sterile and disposable, contained in a double tyvek pouch.
The device is sterilised using ethylene oxide. The device is sterile if its packaging is
not damaged or opened. The expiry date of the device is printed on the package label
("Use By" date).
PRECAUTIONS
• The device must only be used by, or under the direction of, fully trained medical
personnel.
• Do not reuse or re-sterilise; reuse may lead to unknown effects on the patient,
including acute/chronic infection.
• Do not use if the packaging has been opened or is damaged.
• Do not use after the "use by" date indicated on the labels.
• Store in a cool, dry place.
INSTRUCTIONS FOR USE
Device preparation
Only the inner packaging is sterile. Do not place the outer packaging in a sterile area.
Peel the tyvek pouch from the chevron side.
Remove the blister pack from the internal packaging and place it on a sterile surface.
Check that the size reported on each label and on the Dual Collapser matches.
Do not use the device if data do not match.
Grasp the lever of the device to take it out of the blister pack.
Collapsing of the prosthesis
For instructions on Perceval S valve collapsing using the Dual Collapser, please
consult the instructions booklet supplied with the prosthesis.
VALVE
Device name
Perceval S Valve
REF
PVS21/PVS23
PVS25/PVS27
5